IMMULITE TSH THIRD GENERATION CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Tsh Third Generation Control.

Pre-market Notification Details

Device IDK930007
510k NumberK930007
Device Name:IMMULITE TSH THIRD GENERATION CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-04
Decision Date1993-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414953311 K930007 000

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